BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X35MM

    MDR report key: 4771660 · Received May 14, 2015

    Report

    Report Number
    1526439-2015-10439
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 16, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK110216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    INITIAL FUSION L4-S1, S1 SCREW BROKE OFF AT TULIP/SCREW SHANK INTERFACE. REVISION SURGERY REMOVED HARDWARE, REPLACED ALL OF IT AND PLACED TLIF'S AT L4-L5, L5-S1. BROKEN SCREW REMOVED VIA SMALL CONICAL EXTRACTION DRIVER REVERSE THREADED INTO CANNULA OF SCREW, EASY EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316341 SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X35MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention